Clinical trial
Single-center, Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells) in Healthy People Aged 6-17 Years
Name
JSVCT125
Description
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).
Trial arms
Trial start
2024-07-01
Estimated PCD
2024-12-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Recombinant COVID-19 vaccine (Sf9 cells)
This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
Arms:
High-dose vaccine (12-17 years), Low-dose vaccine (6-11 years), Medium-dose vaccine (12-17 years), Medium-dose vaccine (6-11 years)
Placebo control
Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
Arms:
High-dose placebo (12-17 years), Low-dose placebo (6-11 years), Medium-dose placebo (12-17 years), Medium-dose placebo (6-11 years)
Size
600
Primary endpoint
Phase I clinical trial:The incidence of adverse reactions (ARs) .
Day 0-7 days after each vaccination.
Phase II clinical trial:The incidence of adverse reactions (ARs) .
Day 0-7 days after each vaccination.
Phase II clinical trial:The geometric mean titer(GMT) of specific antibody.
Day 30 after completion of 3 doses vaccination
Phase II clinical trial:The geometric mean titer(GMT) of specific antibody.
Day 30 after completion of 3 doses vaccination
Eligibility criteria
Inclusion Criteria:
* Aged 6-17 years;
* The subject and/or guardian can understand and voluntarily sign the informed consent form (double signature is required for 8-17 years old);
* Reproductive women have a negative pregnancy test before each vaccination;
* The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 13.5 months.
Exclusion Criteria:
* History of SARS-CoV-2 infection.
* The COVID-19 antibody (IgG and IgM) screening was positive.
* History of asthma, history of allergy to vaccines or vaccine components, or severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema.
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* Autoimmune diseases or immunodeficiency/immunosuppression.
* Severe chronic diseases that cannot be controlled by drugs, severe cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc.
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
* Any condition caused by thyroid disease or history of thyroidectomy, hypersplenism, or splenectomy.
* Diagnosis of abnormal blood clotting function (for example, lack of clotting factors, coagulopathy, abnormal platelets) or obvious bruising or blood clotting.
* In the past 6 months, received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis).
* Laboratory test results with clinically significant abnormalities (severity level 2 and above) (applicable to phase I clinical trials only).
* Received blood products in the last 3 months.
* Receive other study drugs or vaccines within the past 30 days.
* Vaccination against live attenuated vaccines in the past 30 days.
* Inactivated vaccine or subunit vaccine in the past 14 days.
* Acute disease or acute exacerbation of chronic disease in the last 7 days.
* Axillary temperature\> 37.0°C.
* According to the judgment of the investigator, the subject has other factors that are not suitable for participating in the clinical trial.
Subsequent dose exclusion criteria:
In this trial, the second/third dose of vaccination may be stopped in some cases. This includes allergic reactions, severe hypersensitivity reactions, or grade 3 or higher adverse reactions that cannot be tolerated after previous vaccination/placebo. If these reactions occur, the subject should not continue to receive the second/third vaccination.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}
Updated at
2024-04-24
1 organization
1 product
1 indication
Organization
WestVac BiopharmaProduct
Recombinant COVID-19 vaccineIndication
COVID-19